Hazardous Products Regulations (SOR/2015-17)

Regulations are current to 2018-10-24 and last amended on 2018-04-04. Previous Versions

PART 8Health Hazard Classes (continued)

SUBPART 2Skin Corrosion/Irritation (continued)

Classification in a Category or Subcategory of the Class (continued)

Marginal note:Data available for use of bridging principles

 If data are available to enable the characterization of the mixture as a skin-corrosive mixture or a skin-irritant mixture, in accordance with the bridging principles referred to in subsections 2.3(3) to (8), the mixture must be classified in a category or subcategory of this hazard class in accordance with those subsections.

Marginal note:Data available for ingredients

  •  (1) Subject to subsection (3), a mixture that contains one or more ingredients that are classified in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2” is classified in a category or subcategory of this hazard class in accordance with subsection (2), subject to the following:

    • (a) ingredients that are classified in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2” and are present in the mixture at a concentration equal to or greater than the concentration limit of 1.0% must be included in the calculation of the sum of concentrations of ingredients; and

    • (b) ingredients that are classified in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2” and are present in the mixture at a concentration of less than the concentration limit of 1.0% must be included in the calculation of the sum of concentrations of ingredients only if there is evidence that, at the concentration at which they are present, the ingredients are skin-corrosive substances or skin-irritant substances.

  • Marginal note:Classification — mixture

    (2) A mixture is classified in a category of this hazard class in accordance with the following:

    • (a) if the sum of concentrations of ingredients classified in the category “Skin Corrosion — Category 1” is equal to or greater than 5.0%, the mixture is classified in the category “Skin Corrosion — Category 1”;

    • (b) if the sum of concentrations of ingredients classified in the category “Skin Corrosion — Category 1” is equal to or greater than 1.0% but less than 5.0%, the mixture is classified in the category “Skin Irritation — Category 2”;

    • (c) if the sum of concentrations of ingredients classified in the category “Skin Irritation — Category 2” is equal to or greater than 10.0%, the mixture is classified in the category “Skin Irritation — Category 2”; or

    • (d) if the sum of the results of the following subparagraphs is equal to or greater than 10.0%, the mixture is classified in the category “Skin Irritation — Category 2”:

      • (i) 10 times the sum of concentrations of ingredients classified in the category “Skin Corrosion — Category 1”, and

      • (ii) the sum of concentrations of ingredients classified in the category “Skin Irritation — Category 2”.

  • Marginal note:Mixtures containing particular ingredients

    (3) A mixture is classified in a category of this hazard class in accordance with the following table if it contains one or more substances, such as acids, bases, inorganic salts, aldehydes, phenols or surfactants, which could be corrosive or irritant at concentrations below the concentration limits set out in subsection (2) and at least one ingredient with a concentration that is above the concentration limits set out below:

    TABLE

    ItemColumn 1Column 2Column 3
    CategoryIngredientConcentration Limits
    1Skin Corrosion — Category 1Acid with pH ≤ 2≥ 1.0%
    2Skin Corrosion — Category 1Base with pH ≥ 11.5≥ 1.0%
    3Skin Corrosion — Category 1Other ingredients classified in the category “Skin Corrosion — Category 1”≥ 1.0%
    4Skin Irritation — Category 2Other ingredients classified in the category “Skin Irritation — Category 2”, including acids and bases≥ 3.0%

SUBPART 3Serious Eye Damage/Eye Irritation

Definitions

Marginal note:Definitions

 The following definitions apply in this Subpart.

eye irritation

irritation oculaire

eye irritation means the production of changes in the eye that are fully reversible within an observation period of 21 days. (irritation oculaire)

serious eye damage

lésion oculaire grave

serious eye damage means the production of tissue damage in the eye or serious physical decay of vision

  • (a) for which data demonstrate that it is irreversible; or

  • (b) that is not fully reversible within an observation period of 21 days. (lésion oculaire grave)

Classification in a Category or Subcategory of the Class

Classification of Substances

Marginal note:Order of provisions

 The classification of a substance that causes serious eye damage or eye irritation in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.3.2 to 8.3.7, unless, after applying subsections 8.3.2(1) to (4), the substance is not classified further to subsection 8.3.2(5).

Marginal note:Human or animal data — serious eye damage

  •  (1) A substance for which there are human data or purposely generated animal data with respect to serious eye damage is classified in the category of this hazard class in accordance with the following table:

    TABLE

    ItemColumn 1Column 2
    CategoryCriteria
    1Serious Eye Damage — Category 1

    A substance

    • (a) that, according to human data, causes serious eye damage;

    • (b) that, according to animal data acquired from a scientifically validated method from at least one animal, produces effects on the cornea, iris or conjunctiva

      • (i) that are irreversible as demonstrated by data, or

      • (ii) that are not fully reversible within an observation period of 21 days; or

    • (c) in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion, as amended from time to time, demonstrate a positive response in at least two of three animals, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is

      • (i) in the case of corneal opacity, ≥ 3, or

      • (ii) in the case of iritis, > 1.5

  • Marginal note:Human data — eye irritation

    (2) A substance for which human data demonstrate that it causes eye irritation is classified in the category “Eye Irritation — Category 2”.

  • Marginal note:Animal data — eye irritation

    (3) A substance for which purposely generated animal data demonstrate that it causes eye irritation is classified in the category “Eye Irritation — Category 2” and is, if the applicable data are available, further classified in the appropriate subcategory in accordance with the following table:

    TABLE

    ItemColumn 1Column 2Column 3
    CategorySubcategoryCriteria
    1Eye Irritation — Category 2Eye Irritation — Category 2A

    A substance that is not classified in the category “Serious Eye Damage — Category 1” and in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion, as amended from time to time, demonstrate in at least two of three animals a positive response that fully reverses within an observation period of more than seven days but not more than 21 days, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is

    • (a) in the case of corneal opacity, ≥ 1;

    • (b) in the case of iritis, ≥ 1;

    • (c) in the case of conjunctival redness, ≥ 2; or

    • (d) in the case of conjunctival edema (chemosis), ≥ 2

    2Eye Irritation — Category 2Eye Irritation — Category 2B

    A substance that is not classified in the category “Serious Eye Damage — Category 1” and in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion, as amended from time to time, demonstrate in at least two of three animals a positive response that fully reverses within an observation period of seven days, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is

    • (a) in the case of corneal opacity, ≥ 1;

    • (b) in the case of iritis, ≥ 1;

    • (c) in the case of conjunctival redness, ≥ 2; or

    • (d) in the case of conjunctival edema (chemosis), ≥ 2

  • Marginal note:Skin corrosion data

    (4) A substance that is classified in the category “Skin Corrosion — Category 1” in accordance with subsections 8.2.2(1) and (2) is also classified in the category “Serious Eye Damage — Category 1” of this hazard class.

  • Marginal note:No classification

    (5) A substance that meets the following conditions need not be classified in any category of this hazard class:

    • (a) the substance is not classified further to subsections (1) to (4); and

    • (b) human data or purposely generated animal data on the substance, acquired from a scientifically validated method, with respect to serious eye damage or eye irritation, demonstrate that the substance does not cause serious eye damage or eye irritation.

 
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